Identity
- Trade Name
- DB Swing EUDAMEDDeckenbefestigung FDA UDI
- Generic Name
- Medical monitor/light mount FDA UDI
- Device Name
- Leichtlast EUDAMED
- Model / Reference
- DB Swing EUDAMEDSwing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061591000066 EUDAMEDFDA UDI
- Basic UDI-DI
- 4061591000400QX EUDAMED
- Direct Marketing DI
- 04061591000066 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical monitor/light mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
DB Swing by Ondal Medical Systems Gmbh — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4061591000400QX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ondal Medical Systems GmbH
- EUDAMED SRN
- DE-MF-000000203
Sources (2)
- EUDAMED 57db3a06-91ee-45d0-aac1-ad7810af8c99 61 fields · synced Jul 24, 2026
- FDA UDI c7373b4c-9bbe-4e54-b7ce-e8a416f0d27e 32 fields · synced May 30, 2026